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STRATEGIC-1 Phase 3 Trial: Exploring the influence of age on treatment strategies for RAS/BRAF wild-type mCRC

April, 04, 2023 | Colorectal Cancer, Gastrointestinal Cancer

KEY TAKEAWAYS

  • STRATEGIC-1 trial, Phase 3, compared two treatment regimens in unresectable mCRC patients.
  • The primary aim was to evaluate the impact of age on treatment efficacy.
  • A subgroup analysis of patients ≥70 years old was preplanned.
  • Age had similar predictive values regarding DDC and OS in both treatment arms.
  • OS was significantly improved in Arm A for patients <70 years old.
  • Further studies are needed to better target elderly patients with mCRC.

In clinical practice, patients (pts) with CRC are nearly half as likely to be over 70. In patients with untreated RAS/BRAF wild-type unresectable mCRC, STRATEGIC-1 compared FOLFIRI-cetuximab followed by mFOLFOX6-bevacizumab (Arm A) to OPTIMOX-bevacizumab followed by FOLFIRI-bevacizumab and EGFR monoclonal antibody +/- irinotecan (Arm B). Researchers analyzed disease-free and overall survival (OS) rates to understand how age affects a drug’s effectiveness. Patients younger than 70 years old were preselected for a separate analysis. At the time of diagnosis, pts were split into two groups based on their ages: 70 and 70.

Kaplan-Meier plots were used to represent DDC and OS, and log-rank testing and Cox regression were used to compare the two. Seventy-one percent (187 pts) of the total sample size (N=263) was younger than 70 years old, while only 29 percent (76 pts) were older. Thirty-five patients (27%) and forty-one patients (31%) were ≥70 in Arm A (N=131) and Arm B (N=132), respectively. Both DDC (22.0 months in younger vs. 25.3 months in elderly [HR=0.91, 0.66-1.25; P=0.553]) and OS (36.5 months vs. 34.9 months [HR=1.08, 0.78-1.48; P=0.648]) were similarly predicted by age in subgroup analyses. Although there was a statistically significant improvement in OS in Arm A (HR=1.45, 1.02-2.08; P=0.039) in <70 pts, the median OS in Arm B was better in ≥70 pts (42.1 vs. 33.7 months, but non-significant [P=0.161]).

Although the elderly were underrepresented in the trial compared to real life, these findings confirm the efficacy of polychemotherapy regimens associated with targeted therapies regardless of age. It is still unclear which first-line chemotherapy regimen is ideal for elderly patients. Additional research is required to target the elderly with mCRC better. The COLAGE GERCOR study compared the quality of life for those treated with FOLFOX-bevacizumab to those treated with the current standard of care; capecitabine-bevacizumab is an essential first step.

Source: https://oncologypro.esmo.org/meeting-resources/esmo-congress/impact-of-age-on-treatment-strategies-in-ras-braf-wild-type-metastatic-colorectal-cancer-mcrc-a-prespecified-subgroup-analysis-of-the-gercor-pro

Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01910610

E. Carola, B. Chibaudel, R. Boulahssass, L.M. Dourthe, T. André, J. Henriques, V. Bourgeois, P. Etienne, J. Desrame, O. Dupuis, N. Baba-Hamed, D. Auby, C. Louvet, E. Maillard, C. Tournigand, M. Garcia-Larnicol, E. Shacham Shmueli, B.H. Bird, F. Ghiringhelli, A. de Gramont/390P – Impact of age on treatment strategies in RAS/BRAF wild-type metastatic colorectal cancer (mCRC): A prespecified subgroup analysis of the GERCOR-PRODIGE STRATEGIC-1 phase III study/: A prespecified subgroup analysis of the GERCOR-PRO… | OncologyPRO. (n.d.). Oncologypro.esmo.org. Retrieved March 29, 2023, from https://oncologypro.esmo.org/meeting-resources/esmo-congress/impact-of-age-on-treatment-strategies-in-ras-braf-wild-type-metastatic-colorectal-cancer-mcrc-a-prespecified-subgroup-analysis-of-the-gercor-pro

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